# K052085: Standard, Special, Special+, Sneedle B-Type and Sneedle J-Type Acupuncture Needles

- Pathway: 510(k) (Special)
- Applicant: Asia-Med GmbH and CO KG
- Decided: Oct 14, 2005 after 73 days
- Product code: MQX (Needle, Acupuncture, Single Use)
- Device class: 2
- Regulation: 21 CFR 880.5580
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K111392: Woojeon Acupuncture Needle (=Sera Acupuncture Needle) (2011), 2 descendants of its own
- K141473: SMC Acupuncture Needle (2014), 1 descendant of its own
- K162566: AIK Sterile Acupuncture Needles for Single Use (2017), 0 descendants of its own
- K090910: Hanso Acupuncture Needle (2009), 0 descendants of its own

## Indications for use
Intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

Source page: https://510kreport.com/device/K052085
Methodology: https://510kreport.com/methodology